Where the claims on this site come from.
Every non-trivial claim on this site traces to a source below or to the conference session it accompanies. Each entry states what kind of source it is, when it was published, and when we last reviewed it. When a source is guidance rather than regulation, we say so: the difference matters when you are deciding what a vendor must do versus what a careful buyer should ask.
How to read this register
- Regulation is binding. It defines what covered organizations and products must do.
- Regulatory guidance states an agency's current thinking. It is not binding, but ignoring it is rarely wise.
- Accreditation and professional guidance comes from accreditors and professional bodies. It signals where expectations are heading.
- Educational interpretation is this site's own framing, including the Reverse Canvas method. It is a way to organize buyer questions, not a compliance standard.
Primary sources
The American Society of Health-System Pharmacists' collected resources on digital health and AI in pharmacy practice, including survey data on actual adoption. This is the professional home base for pharmacy AI practice questions.
Publisher: ASHP. Updated continuously. Last reviewed: August 5, 2026.
FDA's guidance on which clinical decision support software functions it regulates as devices. The January 2026 revision narrowed active FDA oversight, which shifted more of the diligence burden onto buying organizations. Guidance, not regulation: it describes FDA's current thinking.
Publisher: FDA. Published: January 2026. Last reviewed: August 5, 2026.
The federal rule that, among other things, requires AI-based decision support in certified EHR technology to publish source attributes: 31 standardized disclosures about how the intervention was built, trained, and validated. If a vendor's product is in this category and the disclosures are missing, that silence is itself an answer.
Publisher: ONC (HHS). Finalized: December 2023, with staged compliance dates. Last reviewed: August 5, 2026.
The certification test method for decision support interventions, including the source-attribute requirements referenced across this site. Useful when you want the exact list of disclosures to request from an EHR-embedded AI vendor.
Publisher: ONC (HHS). Updated with the HTI rules. Last reviewed: August 5, 2026.
Initial joint guidance from the Joint Commission and the Coalition for Health AI on responsible AI adoption in health systems. Not binding today, but it is the clearest public signal of where accreditation expectations are heading. The governance tools on this site are consistent with its direction.
Publishers: Joint Commission and CHAI. Published: September 2025. Last reviewed: August 5, 2026.
Public-record examples
The evidence section of the resource hub cites four public incidents: a December 2023 ASHP Midyear study on chatbot drug-information accuracy, a September 2024 Texas attorney general settlement over overstated accuracy claims, October 2024 Associated Press reporting on a transcription AI inventing content in medical notes, and a March 2026 federal court discovery order involving a payer's care-denial algorithm. These are cited as educational examples of a pattern. This site does not name, rate, endorse, or criticize any vendor, and none of these examples should be read as a statement about any vendor's current product.
Session sources
The Reverse Business Model Canvas method, the five risk categories, the approval gate, the literacy levels, the incident sequence, and the 90-day plan come from the conference session this site accompanies: "AI Risk Management for Pharmacy Leaders: Building Guardrails Before You Need Them", presented by Paul Swider at the Hospital Pharmacy Buyer Conference, August 2026. They are educational interpretation, not regulation.
Review cadence and change log
Regulatory and standards content on this site has a named owner and is reviewed quarterly, or sooner after a material guidance change. Found an outdated source or a claim that needs a citation? Email hi@realactivity.com and we will fix it.
| Date | Change |
|---|---|
| August 5, 2026 | Initial publication of the source register. |